Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

• You will be a member of Pfizer’s dedicated and highly effective Quality Assurance for Technical Transfer & Labs team, where you will:

• Provide Quality support within QC for analytical method transfers and cGMP readiness activities for both existing manufacturing programs (through BLA submission) and new product programs transferred to the site (both clinical and commercial), with focus on quality control/laboratory functions.

• For new product transfers this role involves support of design/enabling/laboratory readiness work according to Pfizer Quality Standards (PQS) and Sanford Standard Operation Procedures (SOPs). The Senior QA associate works to ensure quality oversight of quality and compliance requirements within QC throughout the project life cycle from design through BLA submission, working in partnership with site project management and tech transfer teams.

• As a Senior QA Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

• It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

• Suggest improvements and conduct continuous improvement activities.

• Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.

• Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.

• Provide Quality Review and oversight of site cGXP documentation related to the operation of a laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.

• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.

• Completes QC Analytical System administrative activities compliantly for the QC labs

• Review and approval of validation documents process, cleaning & method validation.

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate's degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.

• Experience in Quality Assurance or Quality Control Laboratories

• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards

• Proactive approach and strong critical thinking skills

• Must be able to work in a team environment within own team and interdepartmental teams

• Excellent communication and interpersonal skills

• Good working knowledge of Microsoft Excel, Word & Project

Nice-to-Have

• Direct QC Analytical transfer experience.

PHYSICAL/MENTAL REQUIREMENTS

• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

• Review and approval of documentation for 6-8 hours at a time

Work Location Assignment: On Premise

Last Day to Apply: November 26, 2024

Relocation Support: YES.

The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and t